Important Safety Instructions - Interacoustics AT235 Instructions For Use Manual

2.3 Important safety instructions

Read this instruction manual carefully and completely before using the product
1. External equipment intended f or connection to signal input, signal output or other connectors shall
comply with relevant IEC standard (e.g. IEC 60950 f or IT equipment). In these situations an optical
isolator is recommended to f ulf ill the requirements. Equipment not complying with IEC 60601-1 shall be
kept outside the patient environment, as def ined in the standard (usually 1.5 meter). If in doubt, contact
qualif ied medical technician or your local representative.
2. This instrument does not incorporate any separation devices at connections f or PC's, printers, active
speakers etc. (Medical Electrical System). A galvanic l isolator is recommended to f ulf ill the
requirements. For saf e setup please ref er to section 2.3.
3. When the instrument is connected to a PC and other items of equipment of a medical electrical system
assure that the total leakage current cannot exceed the saf ety limits and that separations have the
dielectric strength, creepage clearances and air clearances required f ulf illing the requirements of IEC/ES
60601-1. When the instrument is connected to a PC and other similar items be aware of not touching the
PC and patient simultaneously.
4. To avoid the risk of electric shock, this equipment must only be connected to supply mains with
protective earth.
5. Do not use any additional multiple socket-outlet or extension cord. For saf e setup please ref er to section
2.3
6. This instrument contains a coin-type lithium battery. The cell can only be changed by service personnel.
Batteries may explode or cause burns, if disassembled, crushed or exposed to f ire or high temperatures.
Do not short-circuit.
7. No modif ication of this equipment is allowed without Interacoustics authorization.
Interacoustics will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other inf ormation that will assist service personnel to repair those parts of this
audiometer that are designated by the Interacoustics as repairable by service personnel.
8. For maximum electrical saf ety, turn of f the power f rom a mains powered instrument when it is lef t
unused.
9. The instrument is not protected against harmf ul ingress of water or other liquids. If any spillage occurs
check the instrument caref ully bef ore use or return f or service.
10. No part of the equipment can be services or maintained while in use with the patient.
1. Never insert or in any way use the insert headset without a new clean non def ect test tip. Always make
sure that f oam or ear-tip is mounted correctly. Ear tips and f oam are single use.
2. The instrument is not intended to be used in environments exposed to f luid spills.
3. The instrument is not intended to be used in oxygen rich environments or use in conjunction with
f lammable agents.
4. Check calibration if any parts of the equipment is exposed to shock or rough handling.
D-0128073-C – 2022/05
AT23 5 - Instructions for Use - US Page 7